On March 10, 2021 Bavarian Nordic A/S ("Bavarian Nordic" or the "Company") reported its intention to raise new capital through an accelerated bookbuilding process (Press release, Bavarian Nordic, MAR 10, 2021, View Source [SID1234576416]). The offering (the "Offering") of new shares in Bavarian Nordic has now been successfully completed. Reference is made to company announcement no. 4 of 9 March 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Bavarian Nordic has successfully completed a directed issue and private placement of 5,150,000 new shares (the "New Shares") at an offer price of DKK 223 per share, raising gross proceeds to Bavarian Nordic of DKK 1,148.45 million.

The Offering has not been registered under the U.S. Securities Act and was made pursuant to applicable exemptions from the obligation to publish a prospectus in Denmark as well as exemptions from the U.S. Securities Act and the securities laws of other applicable jurisdictions in a directed issue and private placement and subscribed for by eligible institutional and professional investors in Denmark and in certain other jurisdictions at market price and without pre-emption rights for Bavarian Nordic’s existing shareholders.

The net proceeds from the Offering will be used in accordance with company announcement no. 4 of 9 March 2021.

Bavarian Nordic has in connection with the Offering, agreed to undertake a lock-up commitment for 180 calendar days following settlement of the Offering (subject to certain exceptions). In addition, members of Bavarian Nordic’s board of directors and executive management have in connection with the Offering, agreed to undertake a lock-up commitment for 90 calendar days following settlement of the Offering (subject to certain exceptions).

CAPITAL INCREASE
Subject to settlement, a share capital increase will be registered with the Danish Business Authority and the share capital of Bavarian Nordic will hereafter consist of 63,600,112 shares of DKK 10 each, equivalent to a registered share capital of DKK 636,001,120.

The New Shares represent approximately 8.81 % of Bavarian Nordic’s registered share capital before the capital increase and will account for approximately 8.1 % of Bavarian Nordic’s registered share capital upon completion of the capital increase.

ADMISSION TO TRADING AND OFFICIAL LISTING
The New Shares will be issued under the temporary ISIN code DK0061535853. No application for admission to trading and official listing has been, or will be, filed for the New Shares issued under the temporary ISIN code, and the temporary ISIN code will only be registered with VP Securities A/S for subscription of the New Shares. The temporary ISIN code in VP Securities A/S will be merged with the permanent ISIN code for the existing shares, DK0015998017, as soon as possible following registration of the share capital increase with the Danish Business Authority. The New Shares are expected to be admitted to trading and official listing on Nasdaq Copenhagen A/S on or around 15 March 2021.

The admission to trading and official listing of the New Shares is subject to the Offering not being withdrawn prior to the settlement of the Offering and the Company making an announcement to that effect.

EXPECTED TIMETABLE FOR THE OFFERING

Date Event
Friday 12 March 2021 Settlement and payment for the New Shares
Friday 12 March 2021 Registration of the capital increase with the Danish Business Authority
Monday 15 March 2021 Admission to trading and official listing of the New Shares on Nasdaq Copenhagen A/S
Tuesday 16 March 2021 Merger of the temporary ISIN code with the permanent ISIN code
NEW SHARES
The decision to launch an offering of new shares in a directed issue was made pursuant to Article 5a(2) in Bavarian Nordic’s articles of association pursuant to which its board of directors is authorised to make share capital increases without pre-emption rights for the existing shareholders at market price.

The New Shares will rank pari passu in all respects with existing shares in Bavarian Nordic. The New Shares will be negotiable instruments, and no restrictions will apply to their transferability. No shares, including the New Shares, carry or will carry any special rights. Rights conferred by the New Shares, including voting rights and dividend rights, will apply from the time when the capital increase is registered with the Danish Business Authority. The New Shares must be registered in the name of the holder in the Company’s register of shareholders.

MANAGERS
Danske Bank A/S, Jefferies International Limited, Jefferies GmbH and Nordea Danmark, filial af Nordea Bank Abp, Finland are acting as Joint Global Coordinators and Joint Bookrunners (jointly the "Joint Global Coordinators and Joint Bookrunners") in connection with the Offering. Nordea Danmark, filial af Nordea Bank Abp, Finland acts as settlement agent for the Offering.

Kromann Reumert and Latham & Watkins LLP act as Danish and U.S. legal advisors respectively to the Company. Plesner acts as Danish legal advisors to the Joint Global Coordinators and Joint Bookrunners.

On March 10, 2021 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) ("Merrimack" or the "Company") reported its full year 2020 financial results for the period ended December 31, 2020 (Press release, Merrimack, MAR 10, 2021, View Source [SID1234576432]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased that both Ipsen Pharmaceuticals and Elevation Oncology continue to pursue separate clinical stage programs which could result in milestone payments to Merrimack." said Gary Crocker, Chairman of Merrimack’s Board of Directors. "We have continued to see reduced operating expenses and remain focused on conserving cash to ensure that we have sufficient financial resources to capture future potential milestone payments from Ipsen and Elevation."

Fourth Quarter and Full Year 2020 Financial Results

Merrimack reported net loss of $3.0 million for the year ended December 31, 2020, or $0.22 per basic share, compared to a net loss of $17.3 million, or $1.30 per basic share, for the same period in 2019.

Merrimack reported a gain on sale of assets for the year ended December 31, 2020 of $2.1 million compared to $4.9 million for the same period in 2019.

General and administrative expenses for the year ended December 31, 2020 were $5.0 million, compared to $16.2 million for the same period in 2019.

As of December 31, 2020, Merrimack had cash and cash equivalents and investments of $14.0 million, compared to $16.6 million as of December 31, 2019.

As of December 31, 2020, Merrimack had 13.4 million shares of common stock outstanding.

Updates on Programs Underlying Potential Milestone Payments

Ipsen

– On December 1, 2020 Ipsen held a capital markets day briefing with investors. On February 11, 2021 Ipsen released its full year 2020 financial results. In both of these updates Ipsen provided guidance to investors that it may file with the FDA for accelerated approval of ONIVYDE as a treatment of second line small cell lung cancer in 2021. In addition, Ipsen reported that it is continuing to study ONIVYDE in Phase III clinical trials in first line pancreatic ductal adenocarcinoma.

Elevation Oncology

– On November 18, 2020 Elevation Oncology announced that it had raised a $65 million Series B financing. This announcement included confirmation that Elevation’s phase II CRESTONE study evaluating the HER3 monoclonal antibody seribantumab for the treatment of patients with tumors harboring an NRG1 gene fusion is continuing to enroll patients.

On March 10, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that preclinical anti-tumor efficacy in vivo data from its innate cell engager (ICE) AFM24 have been accepted for e-poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, being held on April 10-15 (Press release, Affimed, MAR 10, 2021, View Source [SID1234576521]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In addition, early data from a Phase 1 study evaluating AFM13 preloaded CAR-like cord blood-derived NK cells followed by weekly AFM13 monotherapy in patients with recurrent or refractory CD30-expressing lymphomas at The University of Texas MD Anderson Cancer Center will be presented by Katy Rezvani during a Major Symposium on April 13th.

Poster details:

Title: AFM24 is a novel, highly potent, tetravalent bispecific EGFR/CD16A-targeting Innate Cell Engager (ICE) designed for the treatment of EGFR-positive malignancies

Abstract: 1881

Authors: Jens Pahl, Gabriele Hintzen, Uwe Reusch, Torsten Haneke, Christian Breunig, Sheena Pinto, Cassandra Choe-Juliak, Andreas Harstrick, Wolfgang Fischer, Arndt Schottelius, Joachim Koch, Erich Rajkovic

Poster Release: The e-poster website will be launched on April 10, 2021. All e-posters will be available for browsing on this date. The poster will also be available on the Company’s website – www.affimed.com

Major Symposium Details:

Session Title: Engineering and Modulating Natural Killer (NK) Cells for Cancer Immunotherapy

Session Number: SY30

Talk: CAR-NK, a Drive to the Future of Cell Therapy

Speaker: Katy Rezvani, MD, PhD, Sally Copper Murray Endowed Chair in Cancer Research Professor of Medicine, Chief, Section of Cellular Therapy, Director for Translational Research Medical Director, SCT Laboratory and the GMP Laboratory, Department of Stem Cell Transplantation and Cellular Therapy, MD Anderson

Moderated 30-minute Panel Session for Q&A Date: Tuesday, April 13, 1:30-2:00 pm ET

More details about the programs for the AACR (Free AACR Whitepaper) Virtual Annual Meetings are available online at www.aacr.org.

About AFM13

AFM13 is a first-in-class innate cell engager (ICE) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is Affimed’s most advanced ICE clinical program and is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma or transformed mycosis fungoides (REDIRECT). The study is actively recruiting, and additional details can be found at www.clinicaltrials.gov using the identifier NCT04101331.

In addition, Affimed is studying AFM13 in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive Hodgkin or non-Hodgkin lymphomas. The investigator-sponsored Phase 1 study, conducted at the MD Anderson Cancer Center in Houston, is administering a CAR-like, stable complex of AFM13 pre-loaded cord blood-derived allogeneic NK cells. The study can be found at www.clinicaltrials.gov using the identifier NCT04074746.

About AFM24

AFM24 is a tetravalent, bispecific innate cell engager (ICE) that activates the innate immune system by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.

Affimed is evaluating AFM24 as a monotherapy for patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies. AFM24-101 is a first-in-human Phase 1/2a open-label, non-randomized, multi-center, multiple ascending dose escalation and expansion study and can be found at www.clinicaltrials.gov using the identifier NCT04259450. In addition, Affimed is planning to initiate further studies evaluating AFM24 in combination with adoptive NK cell transfer and in combination with atezolizumab.

On March 10, 2021 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP) (the "company"), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported that its wholly-owned subsidiary, Avid SPV, LLC (the "Issuer"), has priced its sale of $125 million aggregate principal amount of exchangeable senior notes due 2026 (the "notes") in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Avid Bioservices, MAR 10, 2021, View Source [SID1234576385]). The issuance and sale of the notes are scheduled to settle on March 12, 2021, subject to customary closing conditions. The Issuer also granted the initial purchasers of the notes a 13-day option to purchase up to an additional $18.75 million aggregate principal amount of the notes.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The notes will be senior, unsecured obligations of the Issuer, will be fully and unconditionally guaranteed by the company on a senior, unsecured basis, and will accrue interest at a rate of 1.250% per annum payable semi-annually in arrears on March 15 and September 15 of each year, beginning on September 15, 2021. The notes will mature on March 15, 2026, unless earlier repurchased, redeemed or exchanged. Before September 15, 2025, noteholders will have the right to exchange their notes only upon the occurrence of certain events. From and after September 15, 2025, noteholders may exchange their notes at any time at their election until the close of business on the second scheduled trading day immediately before the maturity date of the notes. The notes will be settled in cash, shares of the company’s common stock or a combination of cash and shares of the company’s common stock, at the Issuer’s election.

The initial exchange rate is 47.1403 shares of the company’s common stock per $1,000 principal amount of notes (which represents an initial exchange price of approximately $21.21 per share of the company’s common stock). The initial exchange price represents a premium of approximately 32.5% over the last reported sale price of $16.01 per share of the company’s common stock on March 9, 2021. The exchange rate and exchange price of the notes will be subject to adjustment upon the occurrence of certain events.

The notes will be redeemable, in whole or in part, for cash at the Issuer’s option at any time, and from time to time, on or after March 20, 2024 if the last reported sale price of the company’s common stock has been at least 130% of the exchange price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which the Issuer provides notice of redemption at a redemption price equal to the principal amount of the notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date.

If a "fundamental change" (as defined in the indenture for the notes) occurs, then noteholders may require the Issuer to repurchase their notes for cash. The repurchase price will be equal to the principal amount of the notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the applicable repurchase date.

The net proceeds from the offering are estimated to be approximately $120.6 million (or approximately $138.7 million if the initial purchasers fully exercise their option to purchase additional notes), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses. The Issuer expects to make an intercompany loan to the company of all of the net proceeds from this offering. The company intends to use approximately $11.2 million of such loan to pay the cost of the capped call transactions described below, and to use up to approximately $41.3 million of such loan to redeem all of the company’s outstanding 10.50% Series E Convertible Preferred Stock (assuming such redemption occurs on April 10, 2021, all such shares remain outstanding through such date and none of such shares are converted into the company’s common stock prior to such redemption). The company intends to use the remaining net proceeds for working capital and other general corporate purposes. If the initial purchasers exercise their option to purchase additional notes, the Issuer expects to make an intercompany loan to the company of all of the net proceeds from the sale of additional notes, which the company intends to use to pay the cost of additional capped call transactions and for working capital and other general corporate purposes. The company may also use a portion of such loans for the acquisition of, or investment in, technologies, solutions or businesses that complement the company’s business, although it has no commitments to enter into any such acquisitions or investments at this time.

In connection with the pricing of the notes, the company entered into privately negotiated capped call transactions with the initial purchasers or their affiliates (the "option counterparties"). The capped call transactions cover, subject to customary adjustments, the number of shares of the company’s common stock that initially underlie the notes. The capped call transactions are expected to reduce or offset the potential dilution of the company’s common stock as a result of any exchange of the notes and/or offset any potential cash payments the Issuer is required to make in excess of the principal amount of exchanged notes, as the case may be, with such reduction and/or offset subject to a cap. If the initial purchasers exercise their option to purchase additional notes, the company expects to enter into additional capped call transactions with the option counterparties. The cap price of the capped call transactions will initially be approximately $28.02 per share of the company’s common stock, which represents a premium of approximately 75.0% over the last reported sale price of the company’s common stock of $16.01 per share on March 9, 2021, and is subject to certain adjustments under the terms of the capped call transactions.

In connection with establishing their initial hedges of the capped call transactions, the option counterparties and/or their respective affiliates may purchase shares of the company’s common stock and/or enter into various derivative transactions with respect to the company’s common stock concurrently with, or shortly after, the pricing of the notes, including with certain investors in the notes. This activity could increase (or reduce the size of any decrease in) the market price of the company’s common stock or the notes at that time.

In addition, the option counterparties and/or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to the company’s common stock and/or purchasing or selling the company’s common stock or other securities in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so on each exercise date for the capped call transactions, which are expected to occur during the 40 trading day period beginning on the 41st scheduled trading day prior to the maturity date of the notes). This activity could also cause or avoid an increase or decrease in the market price of the company’s common stock or the notes, which could affect the ability of noteholders to exchange the notes, and, to the extent the activity occurs during any observation period related to an exchange of notes, it could affect the number of shares of the company’s common stock and value of the consideration that holders of the notes will receive upon exchange of the notes.

Neither the notes, nor any shares of the company’s common stock potentially issuable upon exchange of the notes, have been, nor will be, registered under the Securities Act or any state securities laws and, unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any securities, nor shall it constitute an offer, solicitation or sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. The notes will be offered to qualified institutional buyers pursuant to Rule 144A under the Securities Act.

On March 10, 2021 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported two scientific e-posters sharing updated preclinical data will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting, to be held virtually April 10-15 and May 17-21, 2021 (Press release, Surface Oncology, MAR 10, 2021, View Source [SID1234576401]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The e-poster website will be launched at 8:30 a.m. ET on Saturday, April 10, and will remain available for viewing through Monday, June 21.

The posters include preclinical data from Surface Oncology’s two lead clinical-stage antibody therapies: SRF617 (targeting CD39) and SRF388 (targeting IL-27). Summaries are provided below; full posters will be placed on Surface Oncology’s website following the presentations.

Details of the AACR (Free AACR Whitepaper) presentations are as follows:
Presentation Type: e-poster (Abstract: 1802)
Title: CD39 inhibition shapes the transcriptional landscape of myeloid cells and induces proinflammatory states in the CT26 syngeneic tumor model
Lead Authors: Devapregasan Moodley, Ph.D. and Mayra Carneiro

Summary:

SRF617 is a potent inhibitor of CD39 enzymatic activity both in vitro and in vivo.
Increased activity of CD39 results in significant reductions in extracellular ATP and subsequent accumulation of adenosine, contributing to tumor immune escape, induction of angiogenesis and metastatic progression.
Immunological mechanisms associated with CD39 blockade reveal major changes to immunocyte transcriptional landscapes, including upregulation of several proinflammatory genes.
CD39 inhibition predominantly shaped the transcriptional landscape of myeloid cells and dendritic cells, and generally induced proinflammatory conditions.
These findings indicate that CD39 blockade induces proinflammatory responses, supporting future clinical studies of SRF617 in treating patients with cancer.
Presentation Type: e-poster (Abstract: 1607)
Title: IL-27 signaling serves as an immunological checkpoint for NK cells to promote hepatocellular carcinoma in multiple murine models
Lead Author: Turan Aghayev

Summary:

SRF388 is a fully human antibody designed to inhibit the immunosuppressive activity of IL-27.
IL-27 signaling suppresses natural killer (NK) cells within the tumor microenvironment, promoting hepatocellular carcinoma (HCC) development in vivo.
Elevated IL-27RA expression in cancer tissue and elevated EBI3 serum levels are associated with poor prognosis in patients with HCC.
Inhibiting IL-27 signaling leads to tumor growth inhibition and suppressed HCC development in a non-alcoholic steatohepatitis (NASH)-driven HCC model with concomitant enhancement of NK cell activity.
These findings indicate that IL-27 blockade regulates NK cell-mediated control of HCC and is a promising therapeutic target in liver cancer.